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Prometheus and Patentable Subject Matter Under 35 U.S.C. ' 101

By Laural Boone

The recent protracted dispute between Prometheus Laboratories (“Prometheus”) and Mayo Collaborative Services (“Mayo”) has shed some light on the post-Bilski threshold for patent eligibility under 35 U.S.C. ' 101. The first requirement for U.S. utility patents is of course that the claimed invention must fall within the purview of ' 101, i.e., it must be a “new and useful process, machine, manufacture, or composition of matter,” or a “new and useful improvement thereof.” 35 U.S.C. ' 101. These expansive categories are not, however, without limit. Patent protection is not available for laws of nature, physical phenomena, abstract ideas, and mere algorithms. Recent cases have questioned ' 101 patent eligibility in such varied fields as hedge fund management, business methods, methods of treatment, isolated human genes, and biological assays. One example, in the therapeutic treatment field, concerns the Prometheus-Mayo dispute. It was litigated from the California district court all the way up to the Supreme Court, and was decided by the Federal Circuit twice.

Prometheus in the District Court

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